ATTUNE 1517-10-616Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295056065), received between Mar 31, 2020 and Aug 3, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient returned to surgery with restricted range of motion and stiffness. The poly insert was swapped. The implants were well fixed.Affected Side: Left Knee.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 50117278 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS UPSIZED FOR LOOSE FLEXION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23372161 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY INSERT WAS REMOVED DUE TO INFECTION IN THE PATIENT. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21935942 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION RIGHT KNEE. POLY SUBLUXATION. CONVERSION TO HINGE KNEE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17661258 ↗
• InjurySep 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15443126 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP WAS PERFORMED DUE TO INSTABILITY. POLY WAS UPSIZED FROM A 16MM CRS POLY TO A 20MM CRS POLY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15191619 ↗
• InjuryAug 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT IS A LEFT BKA AND USES A WHEEL CHAIR FOR MOBILITY. PATIENT WAS USING HIS R LEG TO ¿PULL¿ HIS WHEELCHAIR ACROSS A GRASSY AREA AND FELT A ¿THUNK¿. HE DID NOT PRESENT FOR EXAM UNTIL 2 WEEKS LATER, AT WHICH TIME X-RAYS SHOWED THE KNEE DISLOCATED. SURGEON AND ASSISTANT WERE UNABLE TO REPRODUCE THE DISLOCATING MECHANISM WHILE THE PATIENT WAS PARALYZED FOR SURGERY. A FEMORAL REVISION WAS PERFORMED, IMPLANTING A HINGED CONSTRUCT. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 12288647 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. A COMPETITOR CEMENT WAS USED. INTERNAL LEFT KNEE PROSTHESIS WAS DONE. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11114364 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. PATIENT HAD MULTIPLE SURGERIES, REVISIONS AND CEMENT SPACERS. PERFORMED AN I&D WASHOUT WITH LINER EXCHANGE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10220522 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. THE PATIENT CAME IN WITH AN INFECTED TOTAL KNEE. THE PRIOR IMPLANTS WERE ALSO A SECOND STAGE OF AN INFECTED KNEE. THE IMPLANTS WERE REMOVED AND A SPACER WAS PLACED IN THE KNEE. THE DEPUY IMPLANTS PERFORMED PERFECTLY. DOI: (B)(6) 2018. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9906634 ↗